Latest Key Developments (Source: Significant Developments)

Sept 7 (Reuters) - Eli Lilly And Co :Lilly takes steps to streamline business, invest in new medicines and drive growth.Eli Lilly - ‍global workforce reductions, including from U.S. voluntary early retirement program, are expected to impact approximately 3,500 positions​.Eli Lilly and Co - ‍expects majority of positions eliminated to come from a U.S. voluntary early retirement program​.Eli Lilly and Co - ‍expects annualized savings of approximately $500 million that will begin to be realized in 2018​.Eli Lilly and Co - ‍Company's reported earnings per share guidance in 2017 will be reduced by amount of charges​.Eli Lilly and Co - ‍expects to incur charges of approximately $1.2 billion pre-tax or $0.80 per share after-tax​.Eli Lilly and Co - ‍there will be no change to company's non-GAAP earnings per share guidance as a result of initiatives​.Eli Lilly and Co - ‍remaining positions eliminated will come from other anticipated workforce reductions, including select site closures​.Eli Lilly and Co - ‍charges will be reflected as asset impairment, restructuring and other special charges in third and fourth quarters of 2017​.Eli Lilly - "‍Annualized workforce savings of approximately $500 million will be about equally split to improve company's cost structure and reinvest in business​".Eli Lilly and Co - ‍voluntary early retirement program announced to U.S. employees on Sept 7, 2017, will be largely completed by December 31, 2017​.
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Aug 30 (Reuters) - Incyte Corp :Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018.Eli lilly and Co - ‍resubmission package will include new safety and efficacy data​.Eli Lilly and Co - Phase 3 program for psoriatic arthritis is expected to begin in 2018.Eli Lilly says ‍companies anticipate FDA will classify application as a Class II resubmission, which will start a new six-month review cycle​.
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Aug 4 (Reuters) - Eli Lilly And Co ::Eli Lilly announces positive results for second phase 3 study of Lasmiditan for the acute treatment of Migraine.Lasmiditan met its primary endpoint in second phase 3 study spartan.Greater percentage of patients treated with Lasmiditan were migraine pain-free compared to placebo.Lasmiditan also met key secondary endpoint for spartan across all three studied doses.Plan to submit new drug application for Lasmiditan to U.S. FDA in second half of 2018.
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July 28 (Reuters) - Eli Lilly And Co ::Says got civil investigative demand from Minnesota's office of Attorney General relating to pricing, sale of insulin products - SEC filing‍​.Says offices of attorneys general in California and Florida have requested information relating to pricing of company's insulin products.Says lost patent exclusivity for Strattera in the U.S. in May 2017, and generic versions of Strattera were approved in the same month.Entry of generic versions of Strattera has caused "rapid and severe" decline in revenue, which will have material adverse effect on results.In May, Japanese Patent Office resumed 1 of 2 remaining demands for invalidation of company's two vitamin regimen patents, brought by Nipro Corp.
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July 25 (Reuters) - Incyte Corp :Incyte Corp - ‍length of time to a resubmission for New Drug Application(NDA) anticipated to be a minimum of 18 months​.Incyte Corp - ‍FDA has indicated that a new clinical study is necessary for a resubmission in order to further characterize benefit/risk across doses​.Says ‍resubmission to FDA for NDA for baricitinib will be delayed beyond 2017​.Incyte Corp - ‍request for an additional clinical study does not impact ongoing clinical trials for baricitinib​.‍Christi Shaw, president of Lilly Bio-Medicines, says "We are disappointed that resubmission will not occur this year"​.Incyte - Lilly's Christi Shaw says ‍disagree with FDA's conclusions, believe existing data demonstrates positive profile supporting baricitinib approval.
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July 24 (Reuters) - Eli Lilly and Co ::Lilly and Nektar Therapeutics announce alliance to develop and commercialize NKTR-358, an autoimmune therapy.Says Nektar will get initial payment of $150 million, is eligible for up to $250 million additional development & regulatory milestones.Says co, Nektar to co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development.Says co, Nektar will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar.Says Nektar will have option to participate in Phase 3 development on an indication-by-indication basis for NKTR-358.Co to be responsible for all costs of global commercialization for NKTR-358; Nektar to have option to co-promote in U.S. under some conditions.Says subject to closing of deal, co expects to incur acquired in-process research and development charge to earnings in 2017 of about $0.09 per share.Says there will be no change to co's 2017 non-GAAP earnings per share guidance as a result of Nektar transaction.FY2017 earnings per share view $4.12 -- Thomson Reuters I/B/E/S.
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The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday.

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